SIGNATURE CARE ANTIFUNGAL CREAM TOLNAFTATE 1%- tolnaftate cream 
BETTER LIVING BRANDS LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Signature Care Antifungal Cream 78805 (2021) ZDP

Active ingredient Purpose

Tolnaftate 1%.............................................................Antifungal

Uses

Warnings

For external use only

Do not use on children under 2 years of age, except under the advice and supervision of a doctor.

When using this product, avoid contact with the eyes

Stop use and ask a doctor if

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Inactive ingredients cetostearyl alcohol, ethylparaben, glycerin, glyceryl, monostearate, petrolatum, propylene glycol, purified water, sodium sulfite, steareth-20, stearic acid

Distributed by Better Living Brands LLC

P.O. Box 99, Pleasanton, CA 94566

1-888-723-3929

Made in China

78805.1

SIGNATURE CARE ANTIFUNGAL CREAM TOLNAFTATE 1% 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-887
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
STEARETH-20 (UNII: L0Q8IK9E08)  
SODIUM SULFITE (UNII: VTK01UQK3G)  
ETHYLPARABEN (UNII: 14255EXE39)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-887-141 in 1 CARTON09/25/2022
114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/04/2022
Labeler - BETTER LIVING BRANDS LLC (009137209)

Revised: 6/2022
Document Id: e2b1d3ec-3ee1-76f2-e053-2995a90accf9
Set id: b02b81d6-8db4-927b-e053-2995a90a3958
Version: 4
Effective Time: 20220630
 
BETTER LIVING BRANDS LLC